BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 5038278 · Received August 28, 2015

    Report

    Report Number
    1818910-2015-29217
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THAT THE BLACK PROTECTIVE CAP IS MISSING. CAPA (B)(4) WAS PREVIOUSLY INITIATED TO FURTHER INVESTIGATE SIG FEM ADPT TORQUE WRENCH BREAKAGE AND IDENTIFY CORRECTIVE ACTIONS. (B)(4) HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF (B)(4). NO FURTHER CORRECTIVE ACTION REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). THE SIG FEM ADPT TORQUE WRENCH ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED BREAKAGE WITHOUT THE INSTRUMENT TO EXAMINE. BASED ON THE INABILITY TO CONFIRM THE REPORTED BREAKAGE OR IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. ALTHOUGH THE NEED FOR CORRECTIVE ACTION WAS NOT ESTABLISHED, (B)(4) WAS PREVIOUSLY INITIATED TO FURTHER INVESTIGATE SIG FEM ADPT TORQUE WRENCH BREAKAGE AND IDENTIFY CORRECTIVE ACTIONS. CO (B)(4) HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CO (B)(4). NO FURTHER CORRECTIVE ACTION REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    BLACK PLASTIC PIECE IS MISSING FROM PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572152 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2012908

    Patients

    Seq Age Sex Outcome Treatment
    1